MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; CREO THREADED 7.5X55MM POLYAXIAL SCREW, COCR HEAD, TI SHANK

Model Number	5146.1757; 1210.1253
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a revision surgery to replace a creo threaded screw that was loose with subsequent hedron spacer backing post-operatively.
Additional Manufacturer Narrative
The device was not available for evaluation.The imaging provided shows possibly a few millimeters of the rod protruding out of the screw head, ensuring that the rod was fully captured by the screw head.Images provided after the device migration shows that the rod slipped out of the screw head at s1 level.Imaging also shows the hedron p spacer appears to have migrated posteriorly and is sitting outside the vertebral bodies.It's possible that improper placement, improper implant sizing, or improper implant height may have contributed to the migration; however, an exact cause of the reported issue could not be determined.
Additional Manufacturer Narrative
A single "creo threaded 7.5x55mm polyaxial screw, cocr head, ti shank" and a single "hedron p spacer" were returned for evaluation.Initial observation of the screw shows deformation/damage on the retaining feature of the screw head that mates with most instruments.This observed damage may have been caused during removal of the implant as it is consistent with damage caused from a mating instrument.Initial observation of the spacer showed no defects, however, superficial damage is observed near the posterior of the implant, possibly from retrieval of the implant.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that there was a revision surgery to replace a creo threaded screw that was loose with subsequent hedron spacer backing post-operatively.

• Brand Name: CREO STABILIZATION SYSTEM
• Common Device Name: CREO THREADED 7.5X55MM POLYAXIAL SCREW, COCR HEAD, TI SHANK
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 15579074
• Report Number: 3004142400-2022-00149
• Device Sequence Number: 12608612
• Product Code: NKB
• UDI-Device Identifier: 00889095130287
• UDI-Public: 00889095130287
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5146.1757; 1210.1253
• Device Lot Number: BAX359BB; BAW740AB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown